An interventional study of breast cancer and breast self- examination education in Women's Health and Health Education, sponsored by Kırklareli University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Kırklareli University · Not applicable, Interventional, and Screening
The study was conducted to determine the effect of breast cancer and breast self-examination (BSE) education on breast cancer fear and health beliefs. The main questions it aims to answer are:
H1: Breast cancer and BSE training given to women will affect the health beliefs of women.
H2: Breast cancer and BSE training given to women will affect the fear of breast cancer among women.
H3: Breast cancer and BSE training given to women will affect the information and behaviour in relation to breast cancer screening among women.
Researchers divided participants into experimental and control groups to examine the effects of breast cancer and breast self-examination education on breast cancer fear and health beliefs. The experimental group received education about breast cancer and breast self-examination and was reminded to perform breast self-examination by phone for six months.
Before beginning the research, women were informed about the aim, duration, and procedures during the research and they were included in the research after written consent was obtained from women accepting participation. Then pre-test data were collected. The collection of data in the research began on 16 October 2017.
In the first stage of the research, pre-test data were collected using the questionnaire form, Champion Health Belief Model Scale, Champion Breast Cancer Fear Scale, and face-to-face interview method, and women were asked to fill out the forms themselves. After the pre-test data were collected, the women were divided into experimental and control groups using a single-blind randomized method.
In the second stage of the research, women in the experimental group were given education about breast cancer and BSE. Slide presentations used during training provided information about breast anatomy and physiology, breast cancer symptoms and risk factors, early diagnosis methods for breast cancer and breast cancer screening programs, and barriers to breast cancer screening programs were discussed. In addition to slide presentations about breast cancer and BSE, women were also given BSE training on a breast examination mannequin and given brochures after training. The training lasted 40-50 minutes. Training was given in groups of 7-9 people and was completed from 2 April 2018 to 30 April 2018. After women in the experimental group were given training, they were called by telephone once per month until 6 months and reminded about doing BSE.
In the final stage of the research, a post-test was applied to women in the experiment and control groups six months after the first training. The posttest applied the questionnaire, CHBMS, and CBCFS for a second time. Attempts were made to determine the effect of the training and counseling on breast cancer health beliefs and fear of breast cancer.
Based on the principle of sufficient and accurate care, women in the control group were given training about breast cancer and BSE in groups of 7-9 people after posttest data were collected and given brochures at the end of training
201 studies on the registry are indexed under Health Education; 72 are open to participants now.
This study's enrollment of 160 is above the median of 126 across 193 interventional studies indexed under Health Education.
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There are 79 female participants in this group. After the pre-test, participants in the experimental group were given breast cancer and breast self-examination training. After the training, they were reminded to do breast self-examination by phone for six months. The post-test was administered six months later.
Other: breast cancer and breast self- examination education
There are 80 female participants in this group. A pre-test was applied to the participants in the control group. The participants in the experimental group were given an intervention for six months, while the participants in the control group were not. A post-test was applied after six months. Based on the principle of sufficient and accurate care, women in the control group were given training about breast cancer and BSE in groups of 7-9 people after posttest data were collected and given brochures at the end of training
The experimental group were given education about breast cancer and BSE. Slide presentations used during training provided information about breast anatomy and physiology, breast cancer symptoms and risk factors, early diagnosis methods for breast cancer and breast cancer screening programs, and barriers to breast cancer screening programs were discussed. In addition to slide presentations about breast cancer and BSE, women were also given BSE training on a breast examination mannequin and given brochures after training. The training lasted 40-50 minutes. After women in the experimental group were given training, they were called by telephone once per month until 6 months and reminded about doing BSE.
Champion Health Belief Model Scale
The CHBMS consists of 6 subscales and 42 items; susceptibility perception of the perceived individual risks of catching breast cancer (3 items), seriousness perception about the perceived degree of individual threat from breast cancer (7 items), benefits perception expressing advantages related to BSE (4 items), barriers perception about perceived obstacles related to BSE (11 items), confidence expressing perceived individual competence in the ability to identify an abnormal breast mass during BSE (10 items) and health motivation subscale (7 items). Each subscale is evaluated separately and total points including the whole scale are not calculated. Women receiving low points for the barrier subscale and high points from the other subscales show positive attitudes and beliefs related to breast cancer and BSE
Time frame: Six mounth
Champion Breast Cancer Fear Scale
Items on the scale investigate emotions like fear, upset, tension, irritation, restlessness, and worry and situations like depression or increased heart rate when breast cancer is considered. The scale contains 8 items and has a five-point Likert response. Responses to the scale are "definitely disagree" 1 point, "disagree" 2 points, "undecided" 3 points, "agree" 4 points and "completely disagree" 5 points. The lowest points that can be obtained from the scale is 8 with the highest points of 40. High points show high levels of fear about breast cancer. For definition of fear levels to breast cancer low levels of fear are 8-15 points, moderate levels of fear are 16-23 points and high levels of fear are 24-40 points.
Time frame: Six mounth
Plan to share: No — Clinical data are not publicly available due to privacy laws. Questions regarding data can be directed to the corresponding author.
Ran from Mar 2018 to primary completion in Oct 2018, 6 months.
Of 147 non-industry interventional studies with no phase under Health Education, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 6 months is below that.
Counting every sponsor, half of 147 studies reached it within 11 months; a quarter within 3 and three quarters within 21.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Kırklareli University